An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers

Study identification

• EU PAS number:
  EUPAS28457
• Study ID:
  36212
• Official title and acronym:
  An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Ireland

  Spain

  United Kingdom
• Study description:
  Psoriasis is a chronic inflammatory skin disorder that results from complex interactions between genes, the immune system, and environmental factors, although the exact cause remains unclear. Skilarence (dimethyl fumarate, DMF) received European marketing authorisation for the treatment of moderate to severe chronic plaque psoriasis in adult patients on 23 June 2017.This study aims to evaluate the long-term safety of Skilarence used for the treatment of patients with moderate to severe psoriasis. The study will evaluate whether the use of Skilarence is associated with an increased risk of serious infections (including serious opportunistic infections such as progressive multifocal leukoencephalopathy), malignancies, or renal impairment as compared with conventional (non-biologic) systemic therapies. In addition, the study aims to describe the use of Skilarence in patient subgroups for which there is missing information. The study is a long-term, non-interventional, observational post-authorisation safety study that will use a prospective cohort design, and data from established registers of patients with psoriasis treated with systemic therapies in Germany, Spain, and the UK and Ireland.
• Study status:
  Ongoing

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

University Medical Centre Hamburg-Eppendorf

Germany

Fundación Academia Española de Dermatologia y Venereología

Fundación de la Academia Española de Dermatología y Venereología Madrid, Spain, University Medical Center Hambug-Eppendorf (UKE) Hamburg, Germany, British Association of Dermatologists Biologics Register Limited (BADBIR) Manchester, United Kingdom

Study timelines

Date when funding contract was signed

Planned:30/09/2018

Actual:17/12/2018

Study start date

Planned:29/03/2019

Actual:14/05/2019

Data analysis start date

Planned:01/04/2027

Date of final study report

Planned:31/03/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Almirall S.A.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)